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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCOOK BIRD'S NEST VENA CAVA FILTER
Generic NameFILTER, INTRAVASCULAR, CARDIOVASCULAR
Regulation Number870.3375
ApplicantCOOK, INC.
P.O. BOX 489
BLOOMINGTON, IN 47402
PMA NumberP850049
Supplement NumberS005
Date Received02/06/1995
Decision Date09/17/1996
Reclassified Date 05/01/2000
Product Code DTK 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR REVISED LABELING
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